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510(k) Data Aggregation
(64 days)
K5 is intended to supply power to and serve as a base for dental devices and accessories. This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and supplying water into the oral cavity through a water line in dental clinical environments.
The K5 Cart, K5 Mount and K5 Swing are designed for dental treatment and are intended for dental use only and are intended for use by trained medical personnel only.
These devices consist of a foot controller, headrest, backrest, seat, armrest, doctor table, unit, dental light, auxiliary table and doctor stool.
These are an AC-powered dental operative unit with accessories, intended to supply power to and serve as a base for other dental devices. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water unit functions.
The provided FDA 510(k) clearance letter and summary for the K5 Cart, K5 Mount, K5 Swing devices (K251491) indicate that these devices are Class I Dental Operative Units and Accessories. Class I devices are generally considered to be low-risk and often demonstrate substantial equivalence through non-clinical testing rather than extensive clinical studies.
The document extensively compares the proposed devices to a predicate device (K5, K233805) to establish substantial equivalence. It does not describe specific acceptance criteria in terms of performance metrics with numerical thresholds for the device's function as a whole. Instead, it relies on compliance with recognized consensus standards and a detailed comparison of technological characteristics.
Therefore, many of the requested details about acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity, or improvement over human readers) are not applicable or not explicitly stated in this type of 510(k) submission for a Class I mechanical device. The "acceptance criteria" here are primarily met by demonstrating compliance with safety and performance standards relevant to dental operative units and showing that any differences from the predicate device do not raise new questions of safety or effectiveness.
Here's an analysis based on the provided document, addressing the points where information is available and noting where it's not applicable for this type of device and submission.
Acceptance Criteria and Device Performance
As a Class I dental operative unit, the "acceptance criteria" are primarily established by compliance with recognized electrical safety, electromagnetic compatibility, and performance standards for dental equipment, along with demonstrating that any differences from a predicate device do not introduce new safety or effectiveness concerns. The performance is assessed qualitatively through compliance with these standards and by direct comparison of functionalities and specifications with the predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit via Standards Compliance) | Reported Device Performance (as demonstrated by compliance/comparison) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | Verified according to IEC 60601-1; electrical safety is equivalent to predicate device. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | Verified according to IEC 60601-1-2; EMC is equivalent to predicate device. |
| Performance (General Dental Unit) | Compliance with ISO 7494-1 (dental units), ISO 7494-2 (dental chairs) | Verified according to ISO 7494-1, ISO 7494-2; performance is equivalent to predicate device. |
| Software Verification & Validation | Compliance with IEC 62304 and FDA Guidance "Content of Premarket Submissions for Device Software Functions" | Updated software verified according to IEC 62304 and FDA Guidance; deemed substantially equivalent despite different software versions, as major functions are identical. |
| Air Pressure Parameters | Min/Max Operating Air Pressure Range | Proposed: 550(min), 600kPa(max) (Different from Predicate: 550(min), 750kPa(max). No explicit "acceptance criteria" stated on this difference other than it does not raise new concerns.) |
| Water Pressure Parameters | Min/Max Operating Water Pressure Range | Proposed: 250(min), 600kPa(max) (Same as Predicate) |
| Patient Load Capacity | Maximum patient weight | Max. 150kg (Same as Predicate) |
| Chair Height Adjustment | Min/Max Chair Height | Proposed: Max. 850±30mm, Min. 450±30mm (Different from Predicate: Max. 840±30mm, Min. 440±30mm. No explicit "acceptance criteria" stated.) |
| Back Rest Angle | Range of backrest articulation | 0°±5° to 70°±5° (Same as Predicate) |
| Head Rest Angle | Range of headrest articulation | Proposed: -90° to 75° (Different from Predicate: -90° to 70°. No explicit "acceptance criteria" stated.) |
Study Details
It's important to differentiate that this 510(k) submission is for a mechanical/electrical dental operative unit, not an AI/software as a medical device (SaMD). Therefore, many of the questions related to AI performance metrics, clinical study design for accuracy/sensitivity, expert readers, and ground truth establishment (common for imaging AI) do not apply to this clearance. The "study" here is primarily a series of non-clinical tests and a detailed comparison to a predicate device.
1. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of typical AI/imaging studies. Performance was demonstrated through compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, IEC 60601-1-6, ISO 7494-1, ISO 7494-2) and direct engineering measurements and comparisons. This involved testing the physical device(s).
- Data Provenance: Not applicable in the sense of patient data. The testing involves engineering and safety evaluations of the manufactured devices.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The device is a dental operative unit, not an AI diagnostic tool requiring expert-established ground truth from medical images. Compliance with engineering standards and functional specifications constitutes the "ground truth" for this device type.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human reader adjudication of diagnostic outputs.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI diagnostic or assistive device for human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as it's not an algorithm-based device in the diagnostic sense. The device performs its intended functions independently (e.g., moving chair, supplying water/air, powering instruments).
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, "ground truth" is established by:
- Compliance with recognized consensus standards: e.g., IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), ISO 7494-1 (Dental Units), ISO 7494-2 (Dental Chairs).
- Engineering specifications and measurements: Verifying that the device meets its design specifications for things like air pressure, water pressure, chair movement ranges, and patient load.
7. The sample size for the training set:
- Not applicable. This is not a machine learning/AI device requiring a training set.
8. How the ground truth for the training set was established:
- Not applicable. No training set is used.
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(279 days)
K5 is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.
A Dental Unit and Chair K5 is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with IEC 80601-2-60. The 3-way syringe is a dental instrument in accordance with EN 1639. It aids the dental application in the mouth of the patient by supplying air, water or spray. This product is designed for use in dentistry only and may only be used by trained medical personnel. K5 is similar to other commercially available products based on the intended use, the technology used, the claims, the electrical power and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate device.
The provided text describes a medical device, the K5, which is a dental operative unit and accessories, including a dental chair. It is a 510(k) submission to the FDA. However, the document does not contain acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or reader performance with or without AI assistance.
The document focuses on demonstrating substantial equivalence to a predicate device (K3, K183347) based on indications for use, technological characteristics, and compliance with various safety and performance standards.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the document. The document discusses compliance with safety standards and functional equivalence to a predicate device, but it does not specify quantitative acceptance criteria for features like diagnostic accuracy, sensitivity, or specificity, nor does it provide a table of reported device performance against such criteria. The device is a dental operative unit, not an AI/diagnostic software, so these types of performance metrics are not applicable in this context.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable in the context of AI/diagnostic software. The document describes non-clinical testing for areas like biocompatibility, cleaning validation, electrical safety, electromagnetic compatibility, and software verification/validation. These tests do not involve a "test set" of clinical data for performance evaluation in the way an AI algorithm would.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a dental operative unit, and its evaluation focuses on safety, functionality, and compliance with engineering standards, not on diagnostic performance or interpretation by experts to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. As there is no "test set" of clinical data for diagnostic performance requiring expert interpretation, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices, particularly AI-powered ones, to assess how human readers' performance changes with AI assistance. The K5 is a dental operative unit, not a diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or AI was not done. The K5 is a physical dental unit with electronics and software for controlling its functions, not an AI algorithm intended for standalone performance evaluation in a diagnostic capacity.
7. The Type of Ground Truth Used
This information is not applicable in the context of diagnostic accuracy. The "ground truth" for the K5 device's evaluation is primarily based on:
- Compliance with recognized standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility).
- Functional performance (e.g., chair movement, fluid delivery, suction) as designed and tested against specifications.
8. The Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" in the context of machine learning or AI algorithms because the K5 is a dental operative unit, not an AI-driven diagnostic or analytical tool.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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